摘要
目的:研制枸橼酸钾泡腾片处方和制备工艺,初步评价泡腾片质量。方法:设计三种工艺制备枸橼酸钾泡腾片,从工艺稳定性、泡腾片性状和崩解时限来评价工艺优劣;采用筛选的工艺条件生产枸橼酸钾泡腾片,从性状、重量差异、崩解时限、pH值、含量测定、稳定性等方面初步评价泡腾片质量。结果:酸碱部分混合制粒法适用于枸橼酸钾泡腾片生产;泡腾片溶液pH值约6.14;3 min内可崩解完全;加速试验3个月合格,6个月出现自然泡腾;长期试验6个月合格,9个月自然泡腾。结论:枸橼酸钾泡腾片处方和工艺条件较稳定,生产研发应重点关注工艺稳定性再提升及包材甄选。
Objective: To study the prescription and preparation technology of potassium citrate effervescent tablets and evaluate its quality. Methods: Three kinds of preparation methods were designed to prepare potassium citrate effervescent tablets. The stability, characteristics of potassium citrate effervescent tablets and disintegration time were evaluated to select the best preparation method. And then, the quality of potassium citrate effervescent tablets produced by the selected method were evaluated in terms of characteristic, weight difference, disintegration time, pH value, content determination and stability. Results: The acid-base partial mixed granulation method was applied to the production of potassium citrate effervescent tablets. The solution of effervescent tablets produced by acid-base partial mixed granulation method was obtained within 3 min with pH 6.14. Results of accelerated test showed that the potassium citrate effervescent tablets was qualified for 3 months and developed natural effervescence at the 6th month. Results of long-term test showed that it was qualified for 6 months and developed natural effervescence at the 9th month. Conclusion: The prescription and preparation conditions of potassium citrate effervescent tablets were stable. Further improvement of stability and packaging selection should be focused in manufacture study.
作者
孙华燕
黄晓舞
白林
SUN Hua-yan;HUANG Xiao-wu;BAI Lin(Preparation Center, Department of Pharmaceutics, PLA General Hospital, Beijing 100853, China)
出处
《中国药物应用与监测》
CAS
2019年第2期71-74,共4页
Chinese Journal of Drug Application and Monitoring
基金
解放军总医院苗圃基金项目(14KMM47)
关键词
枸橼酸钾
泡腾片
质量控制
Potassium citrate
Effervescent tablet
Quality control
